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Evaluation of Toothbrush Bristles in Plaque Reduction

NCT04681885 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-10-15

Study results available
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Summary

The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of interdental plaque with clinical measurement (Plaque Index) and objective measurement (digitally measured plaque area). This study will demonstrate the influence by a type of processing bristles on removal of interdental plaque and determine an agreement between the different evaluation methods.

This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be randomly allocated to three test groups. Subjects will use the assigned toothbrush at baseline appointment and two times a day for a week. Plaque Index and plaque area will be assessed before/after one time use at baseline and Day 7. Subjects will be assigned to another toothbrush after one week wash-out period.

Conditions

  • Plaque, Dental
  • Gingivitis

Interventions

DEVICE

Tapered bristles A

Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .

DEVICE

Tapered bristles B

Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.

DEVICE

End rounded bristles

Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.

Sponsors & Collaborators

  • Sunstar Americas

    lead INDUSTRY

Principal Investigators

  • Franklin Garcia-Godoy, DDS, PhD · The University of Tennessee Health Science Center

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2021-09-17
Completion
2021-09-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04681885 on ClinicalTrials.gov